FDA Product Code DTM: Filter, Blood, Cardiopulmonary Bypass, Arterial Line

Under FDA product code DTM, arterial line blood filters for cardiopulmonary bypass are cleared to remove particulate and gaseous emboli from the arterial perfusion line.

These microporous filters are placed in the arterial line of the heart-lung machine to capture microemboli — including air bubbles, fat particles, and cellular debris — before they enter the patient's circulation, reducing the risk of stroke and organ injury during cardiac surgery.

DTM devices are Class II medical devices, regulated under 21 CFR 870.4260 and reviewed by the FDA Cardiovascular panel.

Leading manufacturers include Sorin Group Italia S.R.L., Bentley Laboratories, Inc. and American Bentley.